Trial Outcomes & Findings for Remote Preconditioning Over Time To Empower Cerebral Tissue (NCT NCT02169739)
NCT ID: NCT02169739
Last Updated: 2021-03-10
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
12 months
Results posted on
2021-03-10
Participant Flow
Participant milestones
| Measure |
Medical Therapy Only
Intensive standard medical secondary prevention stroke treatment as per the recommendations of the American Heart Association/American Stroke Association national guidelines.
|
Ischemic Preconditioning + Medical
Treatment with Cell Aegis remote ischemic preconditioning device once or twice daily for one year, consisting of up to four 5-minute cycles of bilateral upper extremity ischemia separated by five minutes of reperfusion. Patients received intensive standard medical secondary prevention stroke treatment as per the American Heart Association/American Stroke Association national guidelines.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
Medical Therapy Only
Intensive standard medical secondary prevention stroke treatment as per the recommendations of the American Heart Association/American Stroke Association national guidelines.
|
Ischemic Preconditioning + Medical
Treatment with Cell Aegis remote ischemic preconditioning device once or twice daily for one year, consisting of up to four 5-minute cycles of bilateral upper extremity ischemia separated by five minutes of reperfusion. Patients received intensive standard medical secondary prevention stroke treatment as per the American Heart Association/American Stroke Association national guidelines.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
Baseline Characteristics
Remote Preconditioning Over Time To Empower Cerebral Tissue
Baseline characteristics by cohort
| Measure |
Medical Therapy Only
n=2 Participants
Intensive standard medical secondary prevention stroke treatment as per the recommendations of the American Heart Association/American Stroke Association national guidelines.
|
Ischemic Preconditioning + Medical
n=4 Participants
Patients will receive treatment with Cell Aegis remote ischemic preconditioning device once or twice daily for one year. The procedure will consist of up to four 5-minute cycles of bilateral upper extremity ischemia separated by five minutes of reperfusion. Patients will also receive intensive standard medical secondary prevention stroke treatment as per the American Heart Association/American Stroke Association national guidelines.
Ischemic Preconditioning: Patients will undergo ischemic preconditioning once or twice daily for up to four 5-minutes cycles of bilateral upper extremity ischemia separated by 5-minute periods of reperfusion.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74 years
n=99 Participants
|
63.7 years
n=107 Participants
|
67.1 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The medical intervention arm did not undergo ischemic preconditioning
Outcome measures
| Measure |
Ischemic Preconditioning + Medical
n=4 Participants
Treatment with Cell Aegis remote ischemic preconditioning device once or twice daily for one year, consisting of up to four 5-minute cycles of bilateral upper extremity ischemia separated by five minutes of reperfusion. Patients received intensive standard medical secondary prevention stroke treatment as per the American Heart Association/American Stroke Association national guidelines.
|
Ischemic Preconditioning + Medical
Treatment with Cell Aegis remote ischemic preconditioning device once or twice daily for one year, consisting of up to four 5-minute cycles of bilateral upper extremity ischemia separated by five minutes of reperfusion. Patients received intensive standard medical secondary prevention stroke treatment as per the American Heart Association/American Stroke Association national guidelines.
|
|---|---|---|
|
Duration of Adherence to Ischemic Preconditioning Procedure
|
3 Months
Interval 1.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data were not collected since no participants reached the 12-month follow-up
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data were not collected since no participants reached the 12-month follow-up
Outcome measures
Outcome data not reported
Adverse Events
Medical Therapy Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ischemic Preconditioning + Medical
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Latisha Sharma, MD
University of California Los Angeles
Phone: 310-794-6379
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place